Method and device for use in endoscopic organ procedures

ABSTRACT

Methods and devices for use in tissue approximation and fixation are described herein. The present invention provides, in part, methods and devices for acquiring tissue folds in a circumferential configuration within a hollow body organ, e.g., a stomach, positioning the tissue folds for affixing within a fixation zone of the stomach, preferably to create a pouch or partition below the esophagus, and fastening the tissue folds such that a tissue ring, or stomas, forms excluding the pouch from the greater stomach cavity. The present invention further provides for a liner or bypass conduit which is affixed at a proximal end either to the tissue ring or through some other fastening mechanism. The distal end of the conduit is left either unanchored or anchored within the intestinal tract. This bypass conduit also includes a fluid bypass conduit which allows the stomach and a portion of the intestinal tract to communicate.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. Ser. No. 10/351,231 filed Jan.24, 2003 now U.S. Pat. No. 7,220,237, which is a continuation-in-part ofU.S. patent application Ser. No. 10/279,257 filed Oct. 23, 2002 now U.S.Pat. No. 7,229,428, both of which are incorporated herein by referencein their entirety.

FIELD OF THE INVENTION

The present invention relates generally to medical apparatus and methodsand more particularly to devices and methods for dividing a hollow bodyorgan or otherwise restricting or partitioning a certain section of thatorgan, such as a stomach, intestine or gastrointestinal tract as well asdevices and methods for placing a liner within or partially within thehollow body organ.

BACKGROUND OF THE INVENTION

In cases of severe obesity, patients may currently undergo several typesof surgery either to tie off or staple portions of the large or smallintestine or stomach, and/or to bypass portions of the same to reducethe amount of food desired by the patient, and the amount absorbed bythe gastrointestinal tract. The procedures currently available includelaparoscopic banding, where a device is used to “tie off” or constrict aportion of the stomach, vertical banded gastroplasty (VBG), or a moreinvasive surgical procedure known as a Roux-En-Y gastric bypass toeffect permanent surgical reduction of the stomach's volume andsubsequent bypass of the intestine.

Typically, these stomach reduction procedures are performed surgicallythrough an open incision and staples or sutures are applied externallyto the stomach or hollow body organ. Such procedures can also beperformed laparoscopically, through the use of smaller incisions, orports, through trocars and other specialized devices. In the case oflaparoscopic banding, an adjustable band is placed around the proximalsection of the stomach reaching from the lesser curve (LC) of thestomach around to the greater curve (GC), thereby creating aconstriction or “waist” in a vertical manner between the esophagus (ES)and the pylorus (PY) (See Prior Art FIG. 1). During a VBG (See Prior ArtFIG. 2) a small pouch (P) (approximately 20 cc in volume) is constructedby forming a vertical partition from the gastroesophageal junction (GEJ)to midway down the lesser curvature of the stomach by externallyapplying staples, and optionally dividing or resecting a portion of thestomach, followed by creation of a stoma (ST) at the outlet of thepartition to prevent dilation of the outlet channel and restrict intake.In a Roux-En-Y gastric bypass (see Prior Art FIG. 3), the stomach issurgically divided into a smaller upper pouch connected to theesophageal inflow, and a lower portion, detached from the upper pouchbut still connected to the intestinal tract for purposes of secretingdigestive juices. A resected portion of the small intestine is thenanastomosed using an end-to-side anastomosis to the upper pouch, therebybypassing the majority of the intestine and reducing absorption ofcaloric intake and causing rapid “dumping” of highly caloric or “junkfoods”.

Although the outcome of these stomach reduction surgeries leads topatient weight loss because patients are physically forced to eat lessdue to the reduced size of their stomach, several limitations exist dueto the invasiveness of the procedures, including time, generalanesthesia, healing of the incisions and other complications attendantto major surgery. In addition, these procedures are only available to asmall segment of the obese population (morbid obesity, Body Mass index≧40) due to their complications, leaving patients who are consideredobese or moderately obese with few, if any, interventional options.

In addition to surgical procedures, certain tools exist forapproximating or otherwise securing tissue such as the stapling devicesused in the above-described surgical procedures and others such as inthe treatment of gastrocsophogeal reflux (GERD). These devices includethe GIA® device (Gastrointestinal Anastomosis device manufactured byEthicon Endosurgery, Inc. and a similar product by USSC), and certainclamping and stapling devices as described in U.S. Pat. Nos. 5,897,562and 5,571,116 and 5,676,674, Non-Invasive Apparatus for Treatment ofGastroesophageal Reflux Disease (Bolanos, et al) and U.S. Pat. No.5,403,326 Method for Performing a Gastric Wrap of the Esophagus for Usein the Treatment of Esophageal Reflux (Harrison et al) for methods anddevices for fundoplication of the stomach to the esophagus for treatmentof gastro esophageal reflux (GERD). In addition, certain tools asdescribed in U.S. Pat. No. 5,947,983 Tissue Cutting and Stitching Deviceand Method (Solar et al), detail an endoscopic suturing device(C.R.Bard, Inc., Billerica, Mass.) that is inserted through an endoscopeand placed at the site where the esophagus and the stomach meet. Vacuumis then applied to acquire the adjacent tissue, and a series of stitchesare placed to create a pleat in the sphincter to reduce the backflow ofacid from the stomach up through the esophagus. These devices can alsobe used transorally for the endoscopic treatment of esophageal varices(dilated blood vessels within the wall of the esophagus).

Further, certain devices are employed to approximate tissue such as inU.S. Pat. No. 5,355,897 (Pietrafitta) describing the use of a circularstapler to perform a pyloroplasty to create a narrowing at the pylorus.In addition, intraluminal anastomosis, such as bowel anastomosis, usesuturing or stapling and employ tools such as the circular stapler, suchas that described in U.S. Pat. No. 5,309,927 (Welch), U.S. Pat. No.5,588,579 (Schnut et al), U.S. Pat. No. 5,639,008 (Gallagher et al),U.S. Pat. No. 5,697,943 (Sauer), U.S. Pat. No. 5,839,639 (Sauer), U.S.Pat. No. 5,860,581 (Robertson et al), and U.S. Pat. No. 6,119,913 (Adamset al). Such circular staplers are available from Ethicon Endosurgery,Cincinnati, Ohio (Proximate™ and EndoPath Stealth™ staplers, seewww.surgical stapling.com), Power Medical Interventions, New Hope, Pa.,and United States Surgical, a unit of Tyco Healthcare Group LP, Norwalk,Conn.

There is a need for improved devices and procedures. In addition,because of the invasiveness of most of the surgeries used to treatobesity, and the limited success of others, there remains a need forimproved devices and methods for more effective, less invasive holloworgan restriction procedures.

SUMMARY OF THE INVENTION

The present invention provides for improved methods and apparatus forthe transoral, or endoscopic, restriction of a hollow body organ, suchas the creation of a small stomach pouch. For purposes of the presentinvention, the hollow body organ shall include the entiregastrointestinal tract, including, but not limited to, the esophagus,stomach, portions of or the entire length of the intestinal tract, etc.,unless specified otherwise. In the case of the present invention, thesurgeon or endoscopist may insert devices as described below through thepatient's mouth, down the esophagus and into the stomach or intestine asappropriate. The procedure can be performed entirely from within thepatient's stomach or other organ, and does not require any externalincision. The end result of the procedure is the formation of a varietyof organ divisions or plications that serve as barriers or “partitions”or “pouches” that are substantially sealed off from the majority of theorgan cavity. For example, in the case of dividing the stomach, the“pouch” or partitions that are created may seal a small portion of thestomach just below the esophagus to allow only small amounts of food orliquid to be consumed by the patient. This pouch or partition will mimicthe section of stomach sealed off from the majority of the organ in atraditional obesity surgery heretofore described; however, it can beformed and secured entirely from inside the stomach endoscopically,obviating the need for a prolonged procedure, external incisions,minimizing the risk of infections, and in some cases, generalanesthesia.

The methods and tools of the present invention may also be used intreating GERD in that stomach folds just below the esophagus can beacquired and fastened to create a desired “pleat”, thereby effectivelyextending the length of the esophagus and preventing reflux. Preferably,multiple folds of tissue can be acquired to effect this end. Further,features of the present invention would assist in the longevity of theGE Junction (GEJ)/Esophageal pleat as compared to current devices andtechniques as the plication would include a more significant amount ofmuscular tissue. In addition, the devices and methods of the presentinvention may be used to revise or repair failures seen in currentsurgical procedures, such as dilation of the pouch and/or stoma(stomata) formed in a traditional Roux-En-Y gastric bypass, or VBG. Inthese cases, when the stoma dilates or shifts, the tools of the presentinvention would be useful to circumferentially gather tissue at the siteof dilation to narrow it, thereby making the stoma functional again, orby further reducing the volume of an existing pouch which has dilated.

The devices shown and described herein can be used to form a pouch orpartition by the approximation and fixation of a circular section oftissue acquired circumferentially from the walls of the target organ.The tissue acquisition device and fastener may include an acquisitionfeature (utilizing, e.g., a vacuum, and/or some other mechanical methodfor acquiring a circumferential “bite” of tissue), a fixation element(such as a stapling mechanism) and possibly a cutting element. Inaddition, the device may be adapted to receive a standard endoscope toallow viewing of the target region at various points during theprocedure. The devices may be articulatable through a variety ofconventional methods; alternatively, they may be articulated by aendoscope or other articulation device inserted within.

The fastening assembly of the present invention may employ a similardesign and function to those circular staplers heretofore referenced,taking advantage of their ability to deploy multiple rows of stapleswith one actuation, and their relative clinical efficacy in performingother types of fastening (e.g. anastomoses procedures, hemorrhoidplication, etc.). Such devices can be adapted to perform the novelprocedures described herein. Such devices may be adapted to incorporatea tissue acquisition system within the stapler body to allow sufficienttissue to be acquired during a procedure, and other modifications may bedone to enable use of the stapler in these novel procedures.

In the procedures of the present invention relating to treatment ofgastric disorders such as gastroesophageal reflux disease (GERD), or incases of treating obesity, a flexible circular stapler may be insertedtransorally down the patient's esophagus and into the stomach at theregion of the GEJ. Tissue may then be acquired circumferentially aboutthe stapler device, or at least partially about the circumference of thestapler device at some point less than 360 degrees (possibly in a 180degree formation) relative to a longitudinal axis of the device suchthat the tissue acquisition creates a “waist” within the organ volume.Subsequently, the tissue fixation element may then be deployed to fixthe tissue in a manner to promote healing.

As set forth in U.S. patent application Ser. No. 10/188,547 filed Jul.2, 2002, which is fully incorporated herein by reference in itsentirety, the layered tissue structure of, e.g., the stomach, and theamount of desirable tissue acquisition and approximation is described infurther detail. The devices and procedures of the present inventionwould allow the operator to reliably acquire and secure the necessarytype of tissue, such as the muscularis, in creating the circumferentialor curved tissue plication desirable to ensure a lasting, clinicalresult.

Any of the fastening devices described herein may employ, e.g.,bioabsorbable or biofragmentable staples or fixation element. Suchfastening devices would typically dissolve or otherwise degrade leavingonly the fixation region once the desired tissue healing has occurred.The remaining healed tissue, now a tissue “ring” (TR), would besufficiently adhered or healed together to maintain the integrity of thepouch and stoma. In addition, the fastening devices may include coatingsor other secondary features to aid healing, such as resorbable meshes,sclerosing agents, surgical felt, or tissue grafts.

The pouch or partitions may be created by a procedure of the presentinvention to remain permanently within the stomach to restrict itindefinitely. Alternatively, the creation of the pouch or partitions maybe reversible (e.g., once weight loss is achieved, or reflux minimized)or revised (in the event pouch side needs to be modified). Reversal canalso be achieved via various methods such as dilation of the restrictedsection, or, e.g., using an electro-surgical device such as a bovie tocut the restricted section to free the tissue folds. Further, if thephysician so desires, techniques of the present invention may beaugmented or assisted by the use of other techniques such aslaparoscopy. Optionally, techniques of the present invention may becombined with other procedures such as for the treatment of GERD or thetransoral placement of a bypass prosthesis or other type of liner in theintestine to bypass the hormonally active portion of the smallintestine, typically between the stoma to just proximal of the jejunum.Such a liner maybe placed within the orifice of a stoma created bydevices described herein or within stomas created by variousconventional procedures, as also described herein. For present purposes,a stoma refers simply to an artificial or “man made” narrowing within abody organ. The liner may be tubular in construction and made to matchthe diameter of the stoma created by the present invention such thatthey can be hooked together to achieve the desired clinical effect.Additionally, the distal end of the liner may also be anchored to tissuedistally located from the stoma or it may be left unanchored relying onits resilient physical structure to avoid kinking or twisting.

Moreover, such a liner may vary in construction and in placement withinthe stomach. The liner, which acts as a bypass conduit, may also includefenestrations or openings that provide for fluid communication betweenthe stomach cavity (for instance, following a bypass procedure theremaining stomach cavity is commonly referred to as the “gastricremnant”) and/or common duct (e.g., the duct that enters the intestineat the duodenal ampulla), and certain parts of the intestinal tract tomaintain alimentary flow of digestive secretions. Allowing such flow mayfacilitate in preventing adhesions from forming between the liner andregions of the intestines. Such adhesions may typically cause blockageof the common duct with potentially fatal consequences, such as bowelnecrosis. The liner may also include a secondary fluid conduitadjacently positioned along the liner to provide for fluidcommunication. The fluid conduit may thus have a length which is lessthan, greater than, or equal to a length of the liner and sufficient tocommunicate from the inflow point (e.g., gastric remnant or duodenalampulla) and a point in the lower intestine (e.g., near the jejunum).The liner and fluid conduit may also be configured to ensure that theliner and/or fluid conduit does not inhibit fluid communication from thecommon bile ducts, such as channels or fenestrations along their length.The fluid conduit may be attached to the liner as a parallel tube or inany number of configurations. Another variation may have the fluidconduit as a coaxial tube positioned about the liner.

In either case, the liner may define one or more fenestrations orchannels on the portion of the liner in communication with the gastricremnant, and/or at or near the site of the common bile ducts so as toallow fluids to drain from the organ or ducts. The liner and the fluidconduit may be made separately and attached together or they may be madeintegrally from the same material. Also, the liner and/or the fluidconduit may be made of a braided design to inhibit kinking as the devicereacts to the peristalsis motion of the intestines. Another alternativemay utilize a singular liner having one or more channels definedlongitudinally along the outer surface of the liner rather than as aseparate fluid conduit. These channels may form spaces between thetissue and the liner itself to allow for the flow of fluids within thechannels. In another variation of the singular liner, the liner may havefenestrations or openings positioned along its length near or at thezones of active secretion in the intestines to permit fluid flow fromthe organ or bile ducts into the lumen of the liner (so as to preventblockage thereof), while still maintaining a barrier to the majority ofthe intestine to achieve malabsorption and to facilitate “dumping”syndrome upon ingestion of high fat or high caloric foods. Analternative variation of this singular liner may have multiple valvedopenings along its length to allow for the unidirectional flow ofsecretions into the liner, but prohibiting contact between theintestines and the food contents within the liner.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the prior art procedure commonly known as laparoscopicbanding;

FIG. 2 depicts the prior art procedure commonly known as the verticalbanded gastroplasty or “VBG”;

FIG. 3 depicts the prior art procedure commonly know as surgicalRoux-En-Y procedure;

FIG. 4A-4B depicts one variation on a procedure of the presentinvention, showing a cut-away section of the tissue being acquired bythe distal tip of the device of the present invention, and the resultingmodification to the body organ (creation of a “pouch” within thestomach);

FIGS. 5A-5D depict one variation of procedural steps of performing themethods of the present invention, by showing a cross section of an organ(stomach) and the placement of the device to create a narrowing or“pouch” within the organ;

FIG. 5E depicts one variation of a result of the present invention,including a bypassing sleeve installed to bridge from the point of thestoma at the GEJ, to the pylorus, or further into the intestine;

FIGS. 6A-6D shows a schematic depiction of an organ (stomach) followingcompletion of one variation on a procedure of the present invention andthe resulting cross sectional view of the treated region in variousconfigurations;

FIGS. 7A-7F show a variation on the circular tissue acquisition andfixation device of the present invention, including details on the innerworking elements and flexible shaft thereof;

FIG. 8 depicts details of one variation on the distal portion of thecircular tissue acquisition and fixation device of the present inventionshowing an angled annular acquisition space;

FIG. 9 depicts another variation of the tissue acquisition mechanism ofthe circular tissue acquisition and fixation device of the presentinvention;

FIGS. 10A-10B depict variations of the distal working end of the distaltip of the circular tissue acquisition and fixation device of thepresent invention, detailing an anvil designed to be intraprocedurallymanipulated to assist in removal of the circular tissue acquisition andfixation device of the present invention once the desired tissue hasbeen acquired and fixed according to the present invention;

FIG. 11A depicts a variation of a bypass conduit assembly;

FIGS. 11B-11E depict variations on possible cross sections of the bypassconduit assembly.

FIG. 11F depicts a variation of the bypass conduit assembly having anirregular cross section.

FIG. 12 depicts another variation of the bypass conduit assembly butwith the addition of a fluid bypass conduit located adjacent the conduitwall.

FIGS. 13A-13B depict perspective and cross-sectional views,respectively, of another variation of the bypass conduit having acoaxial fluid bypass conduit.

FIG. 14 depicts a perspective view of a braided tubular structure whichmay be utilized for the bypass conduit.

FIGS. 15A-15B depict variations on anchoring devices for the bypassconduit.

FIGS. 16A-16B depict a bypass conduit with a fluid bypass conduitdeployed within a stoma created by a laparoscopic banding procedure.

FIGS. 17A-17B depict a bypass conduit with a coaxial fluid bypassconduit deployed within a stoma created by a laparoscopic bandingprocedure.

FIGS. 18A-18B depict a bypass conduit with spaced apart fenestrationsdeployed within a stoma created by a vertical banded gastroplastyprocedure.

FIGS. 19A-19B depict a bypass conduit having valved fenestrationsdeployed within a stoma created by laparoscopic banding to constrict thestomach cavity and create a stoma.

FIGS. 19C-19F depict variations on maintaining fluid communicationthrough or along the bypass conduit.

FIGS. 20A-20B depict a bypass conduit deployed within a stomach whichhas an intragastric staple line.

FIGS. 21A-21B depict a bypass conduit deployed within a stoma created bya horizontal gastroplasty procedure.

FIGS. 22A-22B depict a bypass conduit deployed within a stoma created bya biliopancreatic diversion procedure.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides, in part, for methods and devices forhollow organ division and restriction, more particularly providingmethods and devices to perform a transoral, endoscopically mediatedstomach reduction for purposes of, e.g., treating obesity. For purposesof the present invention, the hollow body organ shall include the entiregastrointestinal tract, including, but not limited to, the esophagus,stomach, portions of or the entire length of the intestinal tract, etc.,unless specified otherwise.

As previously discussed, the results of some clinical procedures of theprior art are shown in FIGS. 1-3, from a perspective external to thestomach. An example of a result of the procedure in one variation of thepresent invention is shown in FIG. 4A, which depicts an externalanterior view of a stomach organ 100, having an esophagus 101 (cut awayto reveal the esophageal lumen 102), and further depicting acircumferential orifice or stoma 103, configured from staple line 104,producing a pouch (P). Orifice 103 is preferably positioned close to andon the distal side of the gastroesophageal junction (GEJ) at the base ofthe esophagus, and angled toward the lesser curve of the stomach (LC),leaving a stoma or opening having a diameter of approximately 1 cmbetween the pouch (P) and the remaining stomach volume. A desirablepouch (P) volume is between 15-100 cc, preferably 15-20 cc. The orifice103 operates to restrict food from emptying from the pouch, while stillallowing communication between the pouch and the greater stomach volumefor purposes of passage of digestive fluids and secretions andabsorption of nutrients. FIG. 4B depicts an example of a cross sectionalview of the esophagus where it joins the stomach, and further depictsone variation of a tissue acquisition device of the present invention105, actively engaging the tissue to be fastened in a circumferentialfashion.

Method of Hollow Organ Volume Reduction

A clinical work-up, including a physical and mental assessment of thepatient may be performed to determine whether a transoral stomachreduction clinically indicated. This assessment may include inspectingthe esophagus and stomach of the patient to determine whether anycontraindications exist for undertaking the procedure such asulcerations, obstructions, or other conditions that may precludetreatment. Once the assessment has been completed, either in anoperating room with the patient under general anesthesia, or in anendoscopy suite with the patient under sedation, the operator canintroduce a tissue acquisition and fixation device, as shown in FIGS.5A-5D, down the patient's esophagus and into the stomach to a locationjust beyond the GE Junction (GEJ). Once in place, an optionalcalibration device (not shown) such as a balloon or bougie can beinflated or deployed proximally or adjacently to the GE Junction (GEJ)to assist in correctly sizing the pouch to be created. Alternatively,the physician may opt to use direct vision and place an endoscopethrough the main lumen of the tissue acquisition device to view the siteof entry and resultant treatment zone.

FIGS. 5A through 5D depict cross sectional schematic views of theprocedure of the present invention showing tissue being manipulatedwithin a hollow organ, the stomach. FIG. 5A depicts the esophagus (ES)the stomach cavity (SC), including the landmarks of the lesser curve ofthe stomach (LC), the gastroesophageal junction (GEJ), and the pylorus(PY). Tissue layers represented are the serosal layer (SL), themuscularis or fibrous muscular layer (ML), and the mucosal layer (MUC).Further, FIG. 5A shows the tissue acquisition device 105 positionedwithin the esophagus at a location within the stomach cavity (SC)between the lesser curve (LC) of the stomach and the GEJ.

The device 105, includes a main body 106 having at least one lumentherethrough (not shown), an outer portion 107, having a distal end 108containing a fixation mechanism and a proximal end (not shown). Thedevice 105 further comprises an inner portion 109, which has a distalportion 110 containing a fixation mechanism and a proximal portion (notshown) received therein. Once device 105 is positioned in the preferredanatomical location, outer portion distal end 108 and inner portiondistal end 110 are separated by relative movement of inner portion 109within outer portion 107, to expose opening 112. As described in furtherdetail later below, opening 112 is operatively connected to at least onelumen within the main body 106 and provides a force, e.g., a vacuumforce, to facilitate tissue acquisition. Such a force may be provided bya vacuum or by a mechanical element.

As shown in FIG. 5B, in the case of vacuum, once the opening 112 isexposed to the surrounding tissue within the stomach cavity (SC), thevacuum may be activated and tissue 111 may be drawn into the opening 112in an entirely circumferential manner or a substantially circumferentialmanner, i.e., at least partially about the circumference of the deviceat some point less than 360 degrees (possibly in a 180 degree formation)relative to a longitudinal axis of the device. The amount of tissue 111acquired can vary, but the amount drawn is preferably sufficient enoughto result in healing of the fastened sections, thereby creating a tissuering (TR) around the circumference of the fastened tissue. Said tissuering may be formed of various layers of the stomach and may include scartissue and other elements of effective wound healing.

FIG. 5C further depicts the device 105 after the desired amount oftissue 111 has been acquired, outer portion distal end 108 and innerportion distal end 110 may be moved towards one another such that theacquired tissue 111 is clamped therebetween. Device 105 is then actuatedto engage at least one fastening element (not shown) through theacquired tissue 111 thereby fastening it in place in a circumferentialfashion. This fastening step may also include a cutting step to score orotherwise abrade the acquired tissue 111 after it is fastened to enhancethe healing response of the tissue 111 to increase the durability of thetissue ring. In addition, bulking agents, such as collagen, may beinjected at the time the stoma is formed, or thereafter, to aid inhealing and durability of the tissue. Once the tissue 111 has beenfastened or fixed, the tissue acquisition device 105 is then removed. Indoing so, the inner portion distal end 110 of the device may becarefully pulled through the newly-created tissue ring or stoma createdby the procedure so as to minimize stretching of the ring or stoma.Finally, FIG. 5D depicts the stomach showing the final result andplacement of a circumferential tissue ring (TR) or stoma (ST).

As depicted in FIG. 5E, it is also contemplated that the proceduralsteps described above may be followed by the placement of an optionalbypass conduit 113 to create a bypass from the newly created pouch (P)directly to the pylorus (PY) or beyond into the small intestine. Such abypass would channel food directly from the pouch (P) into the smallintestines to achieve a malabsorptive effect in cases where such aneffect may enhance weight loss. Such a bypass conduit 113 may be formedof any suitable biocompatible graft material such as polyester or PTFE,and may be secured to the newly created tissue ring (TR) or stoma (ST)endoscopically using a clip or stent like structure at the anchored endto produce an interference fit within the stoma. Alternatively, thebypass conduit could be placed over the acquisition device of thepresent invention, and secured by the same fastening elements, and atthe same time as the formation of the stoma. In doing so, the end of thebypass graft to be anchored may be placed over the tissue acquisitiondevice such that the end of the graft coincided with the tissueacquisition device opening 112, allowing it to be acquired into thedevice and fastened along with the surrounding tissue. Similarly, thebypass conduit may be anchored in the pylorus (PY) or intestine bysimilar methods, or may just be left unanchored in the intestine toallow for movement due to peristalsis of the intestinal wall.

FIGS. 6A-6D depict variations of the tissue rings and pouches createdusing the method, and variations thereof, described herein. FIGS. 6A and6B depict the results of utilizing the procedure described above,showing a complete circumferential ring, in this variation, created justdistal from the where the esophagus (ES) and the stomach join eachother. FIG. 6B shows a cross section of the stomach and tissue ring (TR)and further depicts the resulting tissue folds 114 acquired by thedevice 105 and the fixation elements 115 deployed to fix the acquiredtissue. This cross section further depicts a cut zone or abraded zone116 as described above. FIGS. 6C and 6D depict another variation inwhich fixation of the acquired tissue in a position centered between thelesser curve of the stomach (LC) and the greater curve (GC) in such amanner that multiple lumens 117, 118 result as shown in FIG. 6D.Although only two additional lumens 117, 118 are shown in thisvariation, a number of lumens may be created in other variationsdepending upon the number of times and positions the tissue is affixed.

One method of the present invention is to use the device 105, or avariation thereof, to modify or otherwise assist in other proceduresthat utilize stomach or organ plication such as those described inco-pending U.S. patent application Ser. No. 10/188,547 earlierincorporated herein by reference, which describes, in part, in furtherdetail methods and devices for stapling regions of the stomach in alinear fashion. In cases where a zone of the stomach is linearlystapled, the device 105 may be employed to create circular stomas ateither end of the linear staple line so as to enhance the efficacy of avolume reduction procedure or to enhance durability of the staple line.It may also be advantageous to place semi-circular or partiallycircumferential fixation zones at various locations within the targethollow organ. The devices and methods described herein are particularlywell-suited for this because of their ability to “gather” the tissue andcreate a circumferential restriction that acts to limit the flow ofmatter, such as food, through the organ.

Devices

FIG. 7 depicts a cross-sectioned view of one variation of tissueacquisition device 120. As shown, device 120 has a main body portion 123which has a proximal end, a distal end, and a main lumen 121 definedtherethrough. Device 120 also has a grip portion 122′ and an opposinghandle portion 122 which may be pivotally attached to main body portion123 such that handle portion 122 is angularly positionable relative togrip portion 122′. Main body portion 123 may further define one or morecircumferentially defined lumens along its length such that these lumensterminate at the distal end of body portion 123 at outer distal portion124. Main body portion 123 further houses main body inner portion 125,which may be an elongate tubular member configured to be slidablypositioned within main body lumen 121 defined through the length of mainbody portion 123. At the distal end of inner portion 125, an inner bodydistal portion 126 may be attached thereto. This distal portion 126 maybe integrally formed onto inner portion 125 or attached separately andmay be used as a clamping member to facilitate the mechanical retentionof tissue invaginated into the device 120. Distal portion 126 may alsofunction as an anvil for reconfiguring fastening members inserted intothe tissue, as further described below. The proximal end of innerportion 125 may terminate proximally of main body portion 123 in a fluidport 127, which may be utilized for fluid connection to, e.g., a vacuumpump (not shown). Alternatively, distal portion 126 may function as thestaple housing and outer distal portion 124 may function as the opposinganvil. In this variation, the fasteners, as positioned within distalportion 126, may be deployed through inner face 128 into the tissueusing an actuation device, as known in the art.

Inner body distal portion 126 may further comprises an inner face 128which may define an anvil or fastener element detent 129. Where innerportion 125 joins with distal portion 126, oneaor more distal ports 132may be defined which are in fluid communication through inner portion125 with fluid port 127. To actuate device 120, handle portion 122 maybe urged to pivot relative to grip portion 122′. Slider pins 130 may befixedly attached to main body inner portion 125 and configured to extendperpendicularly relative to inner portion 125, as shown in FIG. 7B. Pins130 may be operatively connected with handle 122 such that rotation ormovement of handle 122 is translated into the linear motion of innerportion 125. Pins 130 may be positioned within slot 131 which aredefined longitudinally within main body portion 123. Slots 131 may beconfigured to allow limited translational movement of pins 130 therebylimiting the overall translational distance traveled by inner portion125.

Actuation of handle 122 in a first direction may urge pins 130 to slidewithin slots 131 a first direction, e.g., distally, thereby moving innerportion 125 distally, and actuation of handle 122 in a second directionmay urge pins 130 to slide in a second direction, e.g., proximally,thereby moving inner portion 125 proximally. Main body inner portion 125may be actuated to linearly move inner body distal portion 126 relativeto outer distal portion 124 to a desired distance between the two. Whenthe two portions 124, 126 are moved into apposition to one another, acircumferential tissue acquisition chamber or space 200 may be createdabout or defined between the outer surface of inner portion 125, innerdistal portion 126, and outer distal portion 124. Space 200 may be influid communication with distal port 132 and/or optionally through mainbody lumen 121. In operation, a vacuum force may be applied throughdistal port 132 and/or main body lumen 121 to invaginate or draw tissueinto space 200 such that the tissue is held or configured to thenreceive at least one fastening element to affix the tissueconfiguration.

Main body portion 123 may further house driver element 133 withincircumferentially-shaped fastener lumen 134. Driver element 133 may be atubularly shaped member which is configured to traverse longitudinallywithin fastener lumen 134. Disposed distally of driver element 133within fastener lumen 134 are fasteners 135 and fastener pushermechanism 136. Fasteners 135 may comprise any variety of staples ormechanical fasteners which are made from a biocompatible material, e.g.,stainless steel, platinum, titanium, etc., and fastener retentionmechanism 136 may also comprise any variety of staple retainer which isconfigured to hold fasteners 135 within fastener lumen 134 untilfasteners 135 have been pushed or urged out of the lumen 134 and intothe tissue. The proximal end of driver element 133 abuts driver actuator137 in handle portion 122. Handle portion 122 may define a threadedcavity 138 at its proximal end which is configured to correspondinglyreceive and is in operative communication with driver actuator 137,which may also define a threaded insertion surface for mating withthreaded cavity 138. In operation, upon tissue acquisition withincircumferential space 200 and approximation of main body inner distalportion 126 and main body outer distal portion 124, driver actuator 137may be rotated in a first direction so as to matingly engage the threadsof handle portion threaded cavity 138 and thereby engage the proximalend of driver element 133 to cause driver element 133 to move distally.As driver element 133 is advanced longitudinally in a correspondingmanner as driver actuator 137 is rotated, the distal end of driverelement 133 may contact fastener pusher mechanism 136 and actuatingfastener 135 to distally advance and deploy fastener 135 into anyacquired tissue.

Main body portion 123 may be bendable as depicted in FIG. 7C. As shown,the device 201 may be seen in one configuration in which main bodyportion 123 may be configured in an infinite number of differentconfigurations for negotiating pathways within a body. This particularvariation 201 shows handle grip 202 having an opposing actuation handle203 for actuating movement of inner body distal portion 126. Also shownis an optional scope lumen 204 in the handle 202 which may be used forvisualizing the tissue region being treated during deployment or actualtreatment. The flexibility of the main body portion 123 may be imparted,in part, by the use of, e.g., linking multiple rings 211, as shown inthe isometric view in FIG. 7D. A portion 210 of the main body 123 isshown with the covering, control mechanisms, etc., omitted for clarity.Although this variation shows the use of stacked multiple rings, othervariations may also be used as known in the art for flexible and/orarticulatable elongate devices, e.g., endoscopes, etc. A plurality ofindividual rings 211 may be aligned with one another to create a lengthof the main body portion 123. Any number of rings 211 may be useddepending upon the overall desired length of the device or the desiredlength of a flexible portion of the device. Each of the rings 211 mayhave at least one main channel or lumen 212, which when individual rings211 are aligned as a whole, create a main channel throughout the lengthof the device. Each of the rings 213 may also have a number of spacersor protrusions 213 defined on or around the circumference of the devicefor creating pivotable sections for facilitating relative motion betweenadjacent rings 211, as known in the art. Although the rings 211 areshown with two oppositely positioned protrusions 213, any number ofprotrusions 213 may be used as practicable depending upon the degree ofrelative motion desired between adjacent rings 211. Alternatively,device main body 123 may be constructed in part of, e.g., a coil spring,to achieve a similar functional result. Coil springs may be made ofsuperelastic materials, e.g., nitinol, or spring steels made, e.g, fromstainless steels. The main body 123 or main body segments may beconstructed of various biocompatible materials, such as stainless steel,Delrin or other engineering thermoplastics, etc.

FIG. 7E depicts a single ring 211 having the main lumen 212 definedtherethrough. Main lumen 212 may be modified and enlarged to provide achannel having a large enough diameter to receive a conventionalendoscope for possible use with the present device. One example of sucha device may have a lumen diameter of, e.g., 10 mm, with an outerdiameter of, e.g., 18 mm. One or more of such lumens may be createdwithin the annular section 211 to enable linkage of each section 211 toone another by one or several cables or flexible wires (not shown)adapted to be positioned through the lumens. These wires or cables maybe routed through the length of the device and fixed at the proximal endof the main body portion 123.

As shown in FIG. 7F, an optional sheath or thin film 221 may be placedover the device or at least along a portion 210 of the device toencapsulate the linkages and create a smooth shaft surface, while stillmaintaining its flexibility. The sheath or thin film 221 may be made ofa variety of biocompatible materials, e.g., heatshrink polymers,plastics, etc.

FIG. 8 depicts another variation on the distal end of a tissueacquisition device. The inner distal portion 230 is shown defining aninner face 231 and device outer distal portion 232 having an inner face233. The inner distal portion inner face 231 and the outer distalportion inner face 233 may be formed to face one another in appositionand both faces 231, 233 may each be formed at an angle (A) relative to alongitudinal axis of the device main body 123. The angle (A) may rangeanywhere from 0-90 degrees, but is preferably in the range of 15-45degrees, depending on the desired angle of the resulting tissue fixationzone. This variation may be used to allow the operator to position thetissue acquisition device perpendicularly to a surface of the organ tobe treated (for ease of use) while acquiring and fixing the tissue at anangle relative to the tissue surface. In doing so, the operator mayfashion the resulting fixation zone to more closely approximate acurvature of the organ, such as the curvature between the GEJ and the LCof the stomach. FIG. 9 depicts a further variation 240 of the tissueacquisition device in which fenestrations or ports 241 may be definedover the surface of the device inner distal portion 242. Additionalfenestrations or ports 243 may be defined over a portion of the deviceouter distal portion 232, and additional fenestrations or ports 244 mayalso be defined over a surface of body inner portion 245. Theseadditional ports may allow this variation 240 to acquire tissue along alength of the distal end of the tissue acquisition device 240 atmultiple locations therealong. In practice, this method of tissueacquisition may allow the operator some freedom to manipulate theacquired tissue by the relative movement of device inner distal portion242 and the device outer distal portion 232. This technique can alsoassist in positioning the tissue to be fixed, and/or assuring that therequired amount of tissue (e.g. some muscular layers of the organ wall),have been uniformly acquired prior to fixation.

Following fixation, the tissue acquisition device of the presentinvention is withdrawn from the organ. In doing so, care should be usednot to over-dilate or stretch the newly created tissue ring or stoma. Tomitigate any dilation or stretching, the inner distal portion may alsobe modified. FIGS. 10A and 10B depict variations 250, 260 of the tissueacquisition inner distal portion that are adaptable to effectivelyreduce in cross sectional area to allow for easier removal of the tissueacquisition device from the organ once the circumferential fixation zonehas been created. FIG. 10A depicts tissue acquisition device innerdistal end 251 which is pivotally mounted on main body inner portion 253about pin 252. Activation of the pivoting action may be controlled byrelease of an interface between pin 252 and a stay (not shown) housedwithin main body inner portion to activate rotation of inner distal end251, e.g., in a direction 256. The inner distal end 251 may be rotatedby any angle such the inner face 254 is angled or parallel relative tothe longitudinal axis 255 of the device.

FIG. 10B depicts another variation 260 on tissue acquisition innerportion distal end which may have a segmented configuration. In thisvariation 260, the inner portion distal end may be made of a pluralityof individual segments 262 which when collapsed, reduces the diameter ofinner portion distal end to facilitate removal. Thus, during tissueacquisition and/or fixation, the expanded inner distal portion 264 maybe utilized and after the procedure, it may then be compressed radially265 about a pivot 263 to reduce the cross-sectional profile for removalfrom the area.

Additional Bypass Conduit Devices

As mentioned above for FIG. 5E, an optional bypass conduit 113 may beplaced within the stomach cavity (SC) at the site of the narrowing orstoma (ST). Such a conduit may be placed not only in conjunction withthe intragastric staple line described herein, but with various otherconventional procedures to create a bypass from the pouch (P) directlyto the pylorus (PY), or beyond into the small intestines to effect therate at which food is metabolized. It may also further enhance theefficacy of a bariatric procedure by facilitating “dumping syndrome”.One variation on the bypass conduit is seen in FIG. 11A in bypassconduit assembly 270. In this variation, assembly 270 comprises aconduit wall 272, which may be tubular in shape. Bypass lumen 274 may bedefined throughout the length of conduit wall 272. The conduit wall 272may extend between a proximal end 271 and to a distal end 273 and may bemade from a variety of biocompatible materials. For instance, conduitwall 272 may be made from a rubber material or from a polymeric materialwhich may be configured to be lubricious, e.g., Teflon, Nylon, Dacron,PTFE, polyethylene, polystyrene, polyurethane, polyethyleneterephthalate, etc.

To further increase the structural resiliency of the conduit wall 272,an optional reinforcing member 278 may be utilized within the structure.Reinforcing member 278 may include any number of structural enhancementssuch as a coil member as shown in the FIG. 11A. The coil member may bewound in a helical manner along the body of conduit wall 272 eitheralong the entire length or a portion of the length of conduit wall 272.Another variation may have wires positioned longitudinally along conduitwall 272 rather than a coiled member. Alternatively, a wire-framedstructure may be utilized along the conduit wall 272.

In any of these structural enhancements, the reinforcing member 278 maybe disposed in a laminate structure between layers of conduit wall 272material. Alternatively, the reinforcing member 278 may be formedintegrally into the conduit wall 272 by forming the conduit materialabout the member 278. Another variation may have reinforcing member 278adhered onto the outer and/or inner surface of the conduit wall 272through the use of adhesives, sutures, clamps, or any other number ofconventional attachment methods. Moreover, these optional structuralenhancements may be utilized not only in the variation shown in FIG.11A, but in any of the other variations described herein depending uponthe desired structural characteristics.

The proximal end 271 may be affixed or secured to the stomach tissuewithin stomach cavity (SC), to the tissue adjacent to pouch (P), or toother tissue, as further described below. In the present variation,conduit assembly 270 may have a first gasket 275 and a second gasket 276positioned distal of the first gasket 275 along wall 272. Gaskets 275,276 may be made of a rubberized material or a polymeric materialconfigured to be flexible during the deployment of assembly 270. Such agasketed assembly 270 may be used in conjunction with the tissue ring(TR) or stoma (ST), as described in detail above. Upon deployment andpositioning of assembly 270 within the stomach cavity (SC), thesegaskets 275, 276 may be allowed to expand such that first gasket 275 islocated proximally of the stoma (ST) and second gasket 276 is locateddistally of the stoma (ST). A portion of the conduit wall 277 locatedinbetween the gaskets 275, 276 may be in contact with the stoma (ST) andmay be sufficiently flexible to form around the stoma (ST).

When the bypass conduit is properly positioned to extend from thenarrowing, e.g., the stoma, to within the intestinal tract, e.g., to thejejunum or farther, the distal end of the liner may be positioned toextend distally of the duodenal ampulla 323. As explained in furtherdetail below, the duodenal ampulla is a duct which connects the commonbile duct and the pancreatic duct to the duodenum for dischargingdigestive fluids into the duodenum. These fluids (alimentary flow)normally intermix with partially digested food from the stomach cavity(SC). To facilitate such fluid exchange and to prevent the duct frombeing blocked by the liner, the liner may include communications to theinside of the liner, such as fenestrations, or channels alongside theliner wherein the cross section of the liner may be varied to allow suchan exchange.

FIGS. 11B-11E show variations of cross sections of the bypass conduitfrom FIG. 11A which may allow for fluid exchange to occur along theouter surface of the liner. FIG. 11B shows one variation in which theconduit wall 272′ defines one or more longitudinal channels 279 alongthe outer surface of the wall 272′. FIGS. 11C and 11D show variations inwhich the conduit walls 272″, 272′″, respectively, are angled such thatthe contact between the outer surface and the tissue is non-continuous,thereby allowing fluids to seep within or along these spaces or channelscreated between the angled outer surface and the tissue. FIG. 11E showsyet another variation in which the conduit wall 272″″ defines anundulating outer surface forming at least one or more longitudinalchannels 279. These examples of possible irregularly defined crosssections are merely illustrative and are not intended to be limited onlyto these examples. Other variations, as should known to those in theart, are intended to be included herewithin.

As shown in FIG. 11F, these irregular cross sectional areas may extendalong the entire length of the conduit wall 272′ or just partially alongthe conduit wall 272′, as shown. The length of the irregular crosssection may extend just from within the body organ to distal of the bodyorgan, or along any desired length of the conduit wall 272′, dependingupon the desired results.

Another variation on the bypass conduit is shown in FIG. 12 in conduitassembly 280. This variation is similar to that shown in FIG. 11A butwith the addition of a fluid bypass conduit 281 located adjacent toconduit wall 272. The fluid conduit 281 has a proximal end 282 forpositioning within the stomach cavity (SC) and a distal end 283 forpositioning within the intestines distal to the stomach cavity (SC), asdescribed in further detail below. Fluid conduit 281 may be made in avariety of ways; for instance, conduit 281 may be manufacturedseparately from conduit wall 272 and attached to the outer surface ofthe conduit wall 272 using any variety of methods, e.g., adhesives,clamping, etc., in which case conduct 281 may be made from a similar orsame material as conduit wall 272. For instance, fluid conduit 281 maybe made of a braided material, as described above, to inhibit kinking ofthe conduit. Alternatively, conduit 281 may be formed integrally withthe conduit wall 272 as a uniform assembly.

In either case, conduit 281 has a length which is typically coterminouswith the length of the main conduit wall 272 but may be less than orgreater than the length of the main conduit. The conduit 281 may also beconfigured such that the conduit 281 doesn't block the alimentary flowfrom the ducts. The distal end 283 of the conduit 281 may thus terminateproximally of the distal end 273 of the conduit wall 272, or it mayoptionally terminate at or distally of the distal end 273, dependingupon the desired structure and use. Although a single fluid conduit 281is shown in the figure, any number of additional fluid conduits may beincorporated into the assembly. These additional fluid conduits may bealigned in parallel with conduit 281 or positioned variously about thecircumference of the conduit wall 272. Moreover, the additional conduitsmay be made of various lengths depending upon the desired results.Furthermore, although fluid conduit 281 is shown as being parallel withmain conduit wall 272, fluid conduit 281 may be positioned about conduitwall 272 in a helical or spiral manner, or it may be positioned in avariety of ways, e.g., such as a bent or hooked proximal end, etc.

Yet another variation is shown in FIGS. 13A and 13B, which show conduitassembly variation 290. This variation incorporates a fluid bypassconduit 291 which is coaxially positioned about a portion of conduitwall 272. Fluid conduit 291 has a proximal end 292 for positioningwithin the stomach cavity (SC) and a distal end 294 for positioningdistally of the stomach cavity (SC). To maintain the coaxially adjacentlumen 295, support struts 293 may be positioned between fluid conduit291 and conduit wall 272, as seen in FIGS. 13A and 13B, which is across-sectional view taken from FIG. 13A. Support struts 293 may bepositioned circumferential] y between fluid conduit 291 and conduit wall272 in a variety of configurations so long as coaxial lumen 295 issubstantially unobstructed. Support struts 293 may be fabricatedseparately or integrally with conduit wall 272 and/or fluid conduit 291.Alternatively, struts 293 may be extensions of a laminated wireframemaking up the tubular structure for conduit wall 272 and/or fluidconduit 291.

Conduit wall 272 and/or any of its auxiliary fluid conduits may bedirectly fabricated from various materials, as described above.Alternatively, they may be fabricated from an underlying braided tubularstructure such as that shown in bypass conduit variation 300, as seen inFIG. 14. The walls of the conduit may be made of a braided material toform a braided tubular structure 304 defining a bypass lumen 302. Thebraided structure 304 may be made to make the assembly 300 moreresistant to kinking, as is generally known in the art. The tubularstructure 304 may be made, for instance, from superelastic materialslike Nickel-Titanium alloys (nitinol) or from a metal such as stainlesssteel. Such construction may allow for the tubular structure 304 to bebent and twisted 308 in an infinite manner so as to allow the structure304 to flex and move with the stomach without kinking or obstructingflow through the conduit. The braided structure 304 may be coated,covered, or laminated with a biocompatible material to aid in itslubricity; any variety of materials may be used, e.g., polymericmaterials such Teflon, Nylon, Dacron, PTFE, polyethylene, polystyrene,polyurethane, polyethylene terephthalate, etc.

To aid in the secure placement of the bypass conduit proximal to orwithin the stomach cavity (SC), the proximal end 301 of the conduit 304may optionally be radially flared 305 such that the flared portion 305securely contacts the tissue. The flared portion 305 may optionally bereinforced, either by additional braiding or an additional structuralring or band, to create a reinforced region 307 for further ensuringadequate structural support. Moreover, the distal end 303 may also beoptionally flared 306 to assist in anchoring the distal end of thebypass conduit within the intestinal tract or distal to the stomachcavity (SC).

To further facilitate anchoring of a bypass conduit, a number ofalternative anchors may be utilized aside from the gasketedconfiguration described above. Another variation is shown in FIG. 15A inconduit anchoring variation 310. As seen, conduit wall 311 may have afirst gasket 312 and an optional second gasket 313 in which each gasket312, 313 may comprise a coil which is biased to extend radially outward.As above, first and second gaskets 312, 313 may be separated by aconduit portion 314 and a partial length or the entire length of theconduit wall 311 may be reinforced with a reinforcing member 319, asdescribed above.

Another alternative variation to facilitate the anchoring of the bypassconduit may be seen in variation 315 in FIG. I5B. Conduit anchoringvariation 315 may have a reinforced portion or section 317 located nearor at the proximal end of conduit wall 316. This reinforced section 317may comprise a radially expanding portion, much like a self-expandingstmt made of a shape memory alloy such as nitinol; alternatively,section 317 may also comprise a prosthetic ring or gasket made of apolymeric material. Attachment points 318 may be optionally included toproject from the proximal end of conduit wall 316 or from the reinforcedsection 317. These attachment points 318 may be configured to pierceinto the tissue and aid in affixing the conduit 315 by helping to holdthe conduit 315 securely in place along the tissue. The attachmentpoints 318 may be positioned around the circumference of the conduitwall 316 or in any number of configurations as is known in the art.Although the figure shows attachments points 318 as hooks, any number ofdifferent configurations may be utilized, e.g., barbs, clamps, sutures,staples, scents, bands, adhesives, etc., may also be used.

Bypass Conduit Placement

The bypass conduit may be positioned between the stomach cavity (SC) andthe intestines in a variety of ways aside from that shown in FIG. 5Eabove. The bypass conduit assembly 280 may be used in conjunction withvarious gastric procedures. As seen in FIG. 16A, bypass conduit assembly280 may be used with a stomach (SC) which has undergone a laparoscopicbanding procedure. FIG. 16B shows a view of a lap band 321 which hasbeen positioned around a portion of the stomach cavity (SC) below theesophagus (ES) prior to having a bypass conduit deployed. FIG. 16A showsa view of assembly 320 in which conduit assembly 280 has been positionedto extend from the stoma (ST) created by the banding, to a point pastthe pylorus (PY). As shown, the proximal end 271 of the conduit assembly280 may be secured within the stoma created by the lap band 321 usingany of the methods described above. The conduit wall 272 isappropriately sized such that it extends through the stomach cavity (SC)from, in this variation, the stoma (ST) into the intestines, e.g., theduodenum 322, although the distal end 273 may extend farther into theintestinal tract, e.g., to the jejunum. The distal end 273 of theconduit wall 272 may be left unanchored in the intestinal tract or itmay be optionally anchored to the tissue. Anchoring of the distal end273 may be achieved using any of the anchoring methods as describedabove for anchoring of the proximal end 271.

The fluid conduit 281 may be seen in this variation as being positionedalong the conduit wall 272 and within the stomach cavity (SC) such thatits proximal end 282 is placed within the stomach cavity (SC) at thestoma (ST) and its distal end 283 extends past the pylorus (PY) andpartly into the duodenum. Although fluid conduit 281 may be sized tohave a length that is shorter than the conduit wall 272, it maytypically be sized to have a length which is longer than or coterminuswith that of conduit wall 272, and further adapted to facilitate fluidcommunication between the stomach cavity (SC), or gastric remnant, andthe intestines, or the duodenal ampulla 323 and the intestines. Aspositioned, fluid conduit 281 allows for the gastric fluids producedwithin the stomach cavity (SC) and the digestive fluids dischargedthrough the duodenal ampulla (or duct) 323 to intermix and to betransported through the conduit 281 between the stomach cavity (SC) andthe intestine distal of the duodenal ampulla 323. The fluid conduit 281also allows for the fluids to intermix and for the fluids producedwithin the stomach cavity (SC) to drain without contacting any ingestedfoods transported through the bypass conduit 272. If the distal end 283of the fluid conduit 281 extends past the duodenal ampulla 323, theregion of the conduit 281 near or at the entrance to the duct 323 maydefine one or more fenestrations or openings 324 along its length. Thesefenestrations 324 may be positioned and sized appropriately such thatthey allow for the fluid communication between the duct 323 and thelumen of the fluid conduit 281.

FIG. 17A shows another variation 330 utilizing the lap band 321 with thecoaxial fluid bypass conduit 290. FIG. 17B shows a view of the stomachprior to having the conduit assembly 290 deployed. In this variation,fluid conduit 291 may be positioned such that its proximal end is withinthe stomach cavity (SC) and its distal end 294 is positioned within theduodenum 322 to the jejunum, either proximally of or at the duodenalampulla 323. If the distal end 294 is positioned distally of the ampulla323, one or more fenestrations 331 may be defined along the length ofthe fluid conduit 291 to facilitate the fluid exchange and to maintainthe fluid communication, as described above, between the ampulla 323 andlocal intestine and the fluid conduit 291. The use of this coaxiallyadjacent conduit variation allows for the free rotation of the conduitwall 272 and/or fluid conduit 291 about its longitudinal axis within thestomach cavity (SC) without the problems of kinking or improperplacement of the fluid conduit relative to the stomach cavity (SC). Theproximal 271 and distal 273 ends of the conduit wall 272 may be anchoredin much the same manner as described above.

In the case of a stomach which has undergone a vertical bandedgastroplasty (VBG) procedure, the conduit may also be utilized tofacilitate patient treatment. FIG. 18B shows a view of the stomach whichhas had the VBG procedure prior to deployment of the bypass conduit. Asshown, a vertical staple line 341 has been deployed along a portion ofthe stomach extending from the circular defect 342 defined within thestomach to the gastroesophageal junction (GEJ). A silastic band 343 hasalso been positioned to create a narrowing or stoma at the end of thestaple line 341. As shown in the variation 340 of FIG. 18A, the bypassconduit 272 may be deployed such that its proximal end 271 is securedwithin the stoma (ST) created by placement of the silastic band 343 tobypass the stomach cavity (SC) and extend distally through the pylorus(PY), as described above. The conduit may thus extend from within thestomach cavity (SC) to within the intestinal tract. Moreover, one ormore fenestrations 331 may be defined along certain portions of thelength of the conduit wall 272 positioned at active secretory zones(such as within the stomach cavity (SC) and/or the duodenal ampulla) toallow fluid exchange through the walls of the bypass conduit 272 at thepoint of those anatomic structures. By spacing fenestrations 331, andlimiting them to communication with only specified active zones, asingle conduit construction can function both as a sufficient barrierbetween ingested food and the intestine (malabsorption), and a selectedflowpath for digestive fluids.

FIG. 19A shows another variation 350 in which a bypass conduit may beused with a stomach which has undergone laparoscopic banding toconstrict the stomach cavity (SC) and create a stoma. The lap band 343may be used to constrict the stomach such that the original stomach, asindicated by the outline 351, is constricted by the band 343 to create aconstricted stomach, as indicated by the constricted outline 352. Thebypass conduit proximal end 271 may then be secured within the stomacreated by the lap band 343, as described above. Furthermore,fenestrations 331, which may be valved, may be placed along the lengthof the bypass conduit 272 to allow a single conduit to perform the dualfunctions of malabsorption and the maintenance of digestive fluid flow.Such fenestrations may include one-way valves that open to receivefluids from outside the bypass conduit. The valves may be configured toselectively open at regions along the conduit length where the pressurefrom such flow overcomes the force which maintains the valve closed;adequate pressure from the flow may be generated by the fluids such aswithin the gastric remnant or at the inflow of the ducts (duodenalampulla). Such a design would not require specific alignment at flowinlets. FIG. 19C depicts one variation of a one-way valve 354 having adoor or flap 355 hinged or partially secured at 356 to the inside ofbypass conduit wall 272. Flap 355 may be biased to urge the valve shutin the absence of the fluid flow. FIGS. 19D and 19E are illustrativeexamples which show variations on the flap 355. FIG. 19D shows a flap355′ which may be attached to the conduit wall and hinged via notchedsection 356′ about which flap 355′ may rotate. FIG. 19E shows anotherexample in which flap 355″ may be attached about a biased hinge 356″. Ineither case, these examples are merely intended to be illustrative andother methods of flap actuation are intended to be included herein. Inaddition, such selective communication between bypass conduit 272 andrelated organs or intestine can be established by varying the porosityor permeability of certain segments 357, 358 along the length of bypassconduit wall 272, as shown in FIG. 19F. FIG. 19B shows a cross-sectionalview of the bypass conduit wall 272 secured to the stomach wall 353 bythe lap band 343.

Another variation on conduit placement may be seen in conjunction withan intragastic stapling procedure in the variation 360 in FIG. 20A. FIG.20B shows a view of the stomach in which an intragastric staplingprocedure has been performed to create an intragastric staple line 361.To affix a bypass conduit 362 near or at the end of the staple line 361,conduit 362 may utilize an anchor region 363, or stoma, which may useany of the various anchoring methods described above. For instance, anynumber of fasteners, e.g., hooks, barbs, clamps, sutures, staples,stents, bands, adhesives, etc., may be used although FIG. 20A shows ananchor configured as a dent. The anchor region 363 may be placedanywhere along the staple line 361 so long as the anchor region 363 maybe securely affixed between the staple line 361 and the stomach tissue.The distal end 364 of the conduit 362 may remain unanchored or it may beoptionally anchored to the tissue within the duodenum 322, as describedabove.

Yet another variation on conduit placement may be seen in the variation370 in FIG. 21 A. FIG. 21B shows a view of the stomach that hasundergone a horizontal gastroplasty procedure in which a horizontalstaple line 371 is created extending from the lesser curvature (LC) tothe greater curvature (GC′.) of the stomach. A portion of the stomachmay be left unstapled to create a stoma 372 between the esophagus andthe remainder of the stomach cavity (SC). The proximal end 271 of thebypass conduit 272 may be secured within this stoma 372 using any of theattachment methods as described above.

Another variation may be seen in variation 380 in FIG. 22A. In thisvariation, the stomach has undergone a biliopancreatic diversion (BPD)procedure where a small portion of the stomach is partitioned off andthe remaining portion of the stomach may be left or removed. A BPDprocedure is similar to a Jejuno-Ileal Bypass (JIB) procedure in which alarge portion, i.e., about two-thirds, of the stomach is partitioned offand/or removed. FIG. 22B shows a view of a stomach which has beenpartitioned along a staple line 381, which may roughly parallel thelesser curvature (LC) of the stomach extending from the gastroesophagealjunction (GEJ) to near the pylorus (PY). The partitioned-off portion 382may optionally be removed leaving the portion of the stomach extendingfrom the esophagus (ES) directly to the pylorus (PY). Within theremaining portion of stomach, the bypass conduit 272 may be positionedsuch that its proximal end 271 is secured near or at thegastroesophageal junction (GEJ), using any of the methods describedabove, and the distal end 273 may be routed distal of the stomach intothe intestinal tract where it may be unanchored or secured to thetissue.

Yet another variation on conduit placement may include the use ofconventional devices such as those described in U.S. Pat. No. 4,458,681(Hopkins) and in U.S. Pat. No. 4,558,699 (Bashour), which are bothincorporated herein by reference in their entirety. Both patentsdescribe variations on clamps which may be placed across a stomach(externally) to create a stoma therewithin for the passage of foodthrough the stomach. The clamps may be placed over the stomach, e.g.,through conventional laparoscopic procedures, and a bypass conduit maybe placed endoscopically within the stomach such that the proximal endof the conduit is supported by the clamp within the created stoma usingany of the methods described above.

The steps of performing the method of organ division or reduction(transoral stomach reduction) are used to illustrate in detail themethod and devices of the present invention, however the presentinvention is not limited thereby. Use of these steps and the toolsdeployed therein may be varied to achieve a similar result in otherhollow body organs and it is anticipated that such techniques can beemployed to divide or restrict other hollow body organs such as organsof the gastrointestinal tract such as bowel, stomach or intestine, or inprocedures in the bladder (treatment for incontinence by reinforcing thebladder sphincter) or uterus, etc. In addition, as previously mentioned,other procedures such as the treatment of GERD may also benefit from themethods and devices disclosed herein. While certain embodiments havebeen illustrated and described in detail, those having ordinary skill inthe art will appreciate that various alternatives, modifications, andequivalents may be used and that the invention is not intended to belimited to the specifics of these variations.

1. A bypass conduit for placement within a hollow body organ, comprising: a tubular member which defines a main lumen therethrough, a first expandable gasket at a proximal end of the tubular member; a second expandable gasket distal to the first self-expanding gasket; wherein said tubular member is flexible between the first and second expandable gaskets; wherein the main lumen maintains communication from proximal to distal of the hollow body organ; wherein at least a portion of an outer surface of the tubular member is adapted to maintain fluid communication therealong; and wherein tissue is secured between the first and the second gasket by the expansion of the first and second expandable gaskets.
 2. The bypass conduit of claim 1 further comprising a reinforcing member along at least a portion of the tubular member.
 3. The bypass conduit of claim 2 wherein the reinforcing member comprises a coil.
 4. The bypass conduit of claim 1 wherein the tubular member further defines at least one fenestration along a region of a wall of the tubular member.
 5. The bypass conduit of claim 4 wherein the fenestration is adapted to allow one-way fluid flow therethrough.
 6. The bypass conduit of claim 5 wherein the fenestration comprises a one-way valve.
 7. The bypass conduit of claim 1 wherein the outer surface further comprises at least one region of fluid permeable material.
 8. The bypass conduit of claim 1 wherein the outer surface defines at least one channel when placed against tissue of the hollow body organ.
 9. The bypass conduit of claim 1 wherein the outer surface defines at least one channel along at least the portion of the outer surface.
 10. The bypass conduit of claim 9 wherein the channel maintains fluid communication between the hollow body organ and a region distal of the hollow body organ through the channel.
 11. The bypass conduit of claim 9 wherein the tubular member further defines a plurality of additional channels along the outer surface.
 12. The bypass conduit of claim 9 wherein the at least one channel extends between the hollow body organ and a region distal of the hollow body organ.
 13. The bypass conduit of claim 9 wherein the at least one channel extends between a first region distal of the hollow body organ and a second region distal of the first region.
 14. The bypass conduit of claim 9 wherein the at least one channel extends along a length of the tubular member.
 15. The bypass conduit of claim 9 wherein the at least one channel is defined longitudinally along the outer surface.
 16. The bypass conduit of claim 1 wherein the tubular member has a length configured to extend through the hollow body organ.
 17. The bypass conduit of claim 1 wherein a proximal end of the tubular member is adapted to be affixed to tissue adjacent to or within the hollow body organ.
 18. The bypass conduit of claim 17 wherein the proximal end is affixed to the tissue via at least one fastener selected from the group consisting of hooks, barbs, clamps, sutures, staples, stents, bands, and adhesives.
 19. The bypass conduit of claim 17 wherein the proximal end is affixed to the tissue which is formed in a circumferential ring.
 20. The bypass conduit of claim 1 wherein a distal end of the tubular member is positionable distal of the hollow body organ.
 21. The bypass conduit of claim 20 wherein the distal end is affixed to tissue located distally of the hollow body organ.
 22. The bypass conduit of claim 20 wherein the distal end is unanchored.
 23. The bypass conduit of claim 1 wherein the tubular member comprises a braided tubular structure adapted to be resistant to kinking.
 24. The bypass conduit of claim 23 wherein the braided tubular structure is comprised of a superelastic metal.
 25. The bypass conduit of claim 23 wherein the braided tubular structure further comprises a lubricious coating.
 26. The bypass conduit of claim 25 wherein the lubricious coating comprises a polymeric material selected from the group consisting of Teflon, Nylon, Dacron, PTFE, polyethylene, polystyrene, polyurethane, and polyethylene terephthalate. 